Smarter Medicine: New 'Digipill' Submitted to FDA for Approval

[Reefa]

The state-of-the-art pill, produced by Proteus Digital Health, is a breakthrough in the fields of medical care and prescription management.

The US Food and Drug Administration has just accepted the application of the world’s very first "digital pill," which contains a microchip and is capable of transmitting different kinds of information to users' smartphones.

The state-of-the-art pill, produced by Proteus Digital Health, is a breakthrough in the fields of medical care and prescription management. Medical treatment is expected to become more efficient as new opportunities to control how regularly pills are being taken emerge. Additionally, pharmaceutical usage is expected to become more effective, as doctors will be able to monitor the use of drugs.

Currently, almost half of all patients in developed countries neglect to take medicine as prescribed, according to Proteus. The total cost of such losses for the healthcare system in the USA alone totals an estimated $300 billion.

"People are given a bag of pills and told to go away and take them and very often they don’t," Mr. Thompson, the founder of privately-owned Proteus explained to The Financial Times.

The tablet is equipped with a ingestible sensor which sends information that the drug has been taken after it’s reached one’s stomach.

Data is sent to a wearable patch, which is able to forward it to patient’s smartphone or right to his doctor. It is especially important for the treatment of memory disorders, such as Alzheimer’s, schizophrenia and other diseases.

"If you have an elderly person on a clinical trial and you ask her to take a pill for three months you cannot be sure that she has taken it every day. She might not admit it if she hasn’t because she doesn’t want to get in trouble with the doctor," Trevor Jones, a UK pharmaceuticals industry veteran and expert in clinical trials, commented to the Financial Times.

Although there is no guarantee that California-based Proteus’s digipill will be approved by the FDA, the firm has been working for several years to jointly develop a regulatory framework for the new generation of pills.

sputniknews.com

[humble3d]

Related only...

Nanoparticles disguised as blood-cell fragments slip past body's immune defence

Drug-delivery systems coated in platelets used to repair damaged blood vessels.

Researchers say that they have found a way to smuggle drug-carrying nanoparticles past the body’s immune system: by camouflaging them to look like cell fragments found in human blood.

Man-made nanoparticles — created from plastic or metal — can be designed to deliver a cargo of drugs to specific areas of the body. But they are often attacked and swallowed up by the body’s natural defence system, which sees them as foreign invaders.

The disguised particles are not only able to evade detection, but also exploit the natural properties of platelets to treat bacterial infections and to repair damaged blood vessels more effectively than conventional ways of delivering drugs, report the team. The researchers were led by Liangfang Zhang at the University of California, San Diego, and published their work in Nature1 on 16 September.

Zhang’s team began with 100-nanometre-wide particles made of the biodegradable polymer PLGA, and coated them in membranes taken from human platelets — cell fragments found in the blood that accumulate at sites of tissue damage and begin the clotting process. This helps the particles to evade the immune system, the authors say.

Researchers have previously tried to attach key parts of platelet membranes onto nanoparticles to avoid immune attack; in particular, the platelet’s CD47 protein. That protein sends out a 'don’t eat me' signal to the body's immune system, says Dennis Discher, a nanoengineer at the University of Pennsylvania in Philadelphia. But Zhang's nanoparticles boast the most complete set of membrane proteins yet, says Omid Farokhzad, a physician and nanotechnologist at the Brigham and Women’s Hospital in Boston, Massachusetts, who wrote a News & Views article that accompanied the paper.

Cloaked assassins

The platelet-coated nanoparticles have other advantages. Bacteria such as methicillin-resistant Staphylococcus aureus (MRSA), for instance, can stick to platelets — a feature they exploit to protect themselves from the immune system. This makes them naturally more likely to interact with coated nanoparticles. Platelets are also attracted to specific areas of the body where tissue damage is occurring.

The particles harness platelets' unique natural abilities, says Samir Mitragotri, a chemical engineer at the University of California, Santa Barbara, who was not involved in the work. “This a highly innovative approach,” he adds.

Zhang’s team injected cloaked nanoparticles — with antibiotics inside — into mice infected with MRSA. This reduced MRSA bacteria populations in the liver and spleen by 1,000 times compared to when mice were given conventional antibiotics, and required just one-sixth of the conventional drug dose. (In other organs nanoparticles were also more effective than conventional drug delivery, but the difference was less pronounced).

The team also exploited the fact that platelets tend to migrate to damaged blood vessels. They loaded camouflaged nanoparticles with a drug called docetaxel, to see if it could prevent the excess thickening of damaged artery walls (an effect that can cause problems after surgery). When these nanoparticles were injected into rats that had damaged blood vessels, the particles clustered in larger concentrations at the damaged sites than in the rats' healthy tissue. And the docetaxel treatment was more effective when delivered this way than when it was delivered into the blood stream without using nanoparticles, the team showed.

The ability to deliver high drug doses to these sites while avoiding immune-system cells called macrophages, which usually destroy most nanoparticles even at disease sites, is impressive, says Discher.

Question marks

But not everyone is convinced about the particles' cloaking ability. Although a small fraction of the particles clustered at sites of disease, the vast majority of them quickly ended up in the animals’ liver and spleen — suggesting that the majority of particles were still being caught by immune defences in those locations, says Moein Moghimi, a specialist in nanotechnology pharmaceuticals at the University of Copenhagen. Moghimi thinks that a much more stringent examination of the body’s immune response to the particles is needed.

Zhang says that his team next plans to make larger amounts of the cloaked nanoparticles, and to test their use in larger animals before therapies could begin trials in humans. Because platelets tend to cluster around cancer cells in the blood, as well as around bacteria, the team will next see whether cloaked nanoparticles could be used to target cancer, he adds.

Developing therapies from hybrid nanoparticles that combine synthetic and biological components will be a long and bumpy road, says Farokhzad. “But is this a technology I would bet on? Absolutely. I think the promise is huge."

Nature doi:10.1038/nature.2015.18380

http://www.nature.com/news/nanoparticles-disguised-as-blood-cell-fragments-slip-past-body-s-immune-defence-1.18380

Nanocapsule able to protect nutrients in beverages and food supplements

(Nanowerk News) Researchers at the National University of Mexico (UNAM) developed a nanostructured system capable of protecting the active compounds of juices and nutritional supplements from high temperatures during the pasteurization process, in order to retain their nutritional properties.

Maria de la Luz Zambrano Zaragoza, researcher at the Nanotechnology area, explained that the benefits of the development called "Nanostructured systems as thermal protectors of functional ingredients in foods" are maintaining the natural compounds, "and what you read on the label is really present during the storage time of the product before its expiration date."

The research began in 2007 with the study of beta-carotene, a pigment found in plants, fruits and vegetables that can be used as an antioxidant.

"The aim was to analyze if by placing a protective layer surrounding the beta-carotene, it lost less nutritional properties during pasteurization; so we designed nanocapsules measuring less than 500 nanometers, and made a gum-like model that has a liquid center. In our case the gum wall is a biodegradable polymer that protects the liquid center: beta carotene," said the responsible for the academic research.

These nanocapsules would be added to the commercial drink. The consumption of the system designed in the Laboratory of Transformation and Emerging Technologies in Food has no contraindications, because it prevents interaction with our cellular system. Besides being composed of a biodegradable polymer, it becomes a lactic acid and can easily be discarded.

"We tested it in orange, strawberry and watermelon juice at 70 and 90 degree Celsius, then we quantified the beta-carotene in the samples and found that degradation is minimal, we had a loss of only 30 percent compared to the traditional loss of about 50 to 60 percent," said the university academic.

In addition to improving retention of betacarotene in thermal processes, the use of nanocapsules can be applied to other antioxidants in processes such as sterilization or UHT.

The research received the second place in the award of the "Programme for the Promotion of Patenting and Innovation" (PROFOPI 2014-2015) in Mexico, which aims to promote the culture of industrial property in the university.

This scientific development is in the process of patenting. The benefit obtained by using the nanostructured food system is less addition of active substances usually required during production, so the storage means less product degradation by the effect of environmental conditions.

Source: Investigación y Desarrollo

http://www.nanowerk.com/nanotechnology-news/newsid=41323.php